Complete Participant contact information sheet at consent. Form in CREDIT documents library

Eligibility Criteria:

3.3.1 Patient must be ≥ 18 years of age at the time of registration.

3.3.2 Patient must have been between the ages of 15-39 at the time of their first primary cancer diagnosis of Hodgkin Lymphoma or Non-Hodgkin lymphoma (NHL).

3.3.3 Patient must have completed therapy (with a complete response, per clinician determination) at the time of registration.

3.3.4 Patients last date of prior systemic therapy for first primary diagnosis for Hodgkin Lymphoma or Non-Hodgkin Lymphoma must have been within one year prior to registration.

NOTE: Systemic therapy refers to all anti-cancer therapy, including but not limited to chemotherapy, IV or oral targeted medications, or radiation, and administered via a clinical trial or standard approach.

3.3.5 Patient must have an ECOG Performance Status of 0-3.

3.3.6 Patient must be English speaking in order to be able to complete the required QOL forms on this study.

NOTE: Sites cannot translate the associated QOL forms.

3.3.7 Patient must not be receiving active therapy for Hodgkin Lymphoma or Non-Hodgkin Lymphoma.

3.3.8 Patient must have internet access through computer, tablet, or smartphone.

3.3.9 Patient must have email address.

3.3.10 Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. 

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELGIBILITY LIST** 

Eligibility Criteria

Patient Eligibility Criteria for Step 0 (OPEN Screening Registration)

-Patient must be ≥ 18 years of age.

- Patient must be fluent in written and spoken English OR Patient must be fluent in written and spoken Spanish

- Patient must present with new or established pathologically proven HR+ HER2- metastatic breast cancer at the time of Step 0.

- Patient must have initiated any of the CKD4/6 inhibitors (Palbociclib or Ibrance, Ribociclib or Kisqali, Abemaciclib or Verzenio) within 30 days prior to consenting to Step 0 or have received a prescription order with stated intent to initiate within 30 days following Step 0 consent.

NOTE: Patients who have been treated previously with anticancer treatments other than CDK4/6 inhibitors are eligible. NOTE: CDK4/6 inhibitors must be provided/supplied as a single agent blister pack. If the medication is supplied as capsules in a pill bottle (e.g., Ibrance capsules), patient is not eligible.

NOTE: Ribociclib (Kisgali) and Abemaciclib (Verzenio) are only available in blister packs. Palbociclib (Ibrance) is the only CDK4/6 inhibitor that might be available in a capsule formulation. However, this is an outdated formulation and is rarely prescribed as a new start. The format of ordered Palbociclib can be determined based on the prescription order.

- Patients must not have been previously treated with any of the following CDK4/6 inhibitors: Palbociclib or Ibrance, Ribociclib or Kisqali, and Abemaciclib or Verzenio.

- Patients must not already be enrolled in a therapeutic clinical trial that monitors CDK4/6 inhibitors.

- Patient must confirm that they intend to receive their care or monitoring at an NCORP site.

- Patient must have a personal mobile phone in which they are able and willing to send and receive text messages. 

NOTE: The restriction to those with mobile phone access with text messaging is based on the primary intention of the study which involves the use of text messaging to improve adherence.

- Patient must have an email address.

NOTE: The restriction to those with an email address is based on the primary intention of the study which involves patients responding to questions regarding their reasons for non-adherence after every missed dose to improve adherence.

- Patient must have the ability to understand and the willingness to sign a written informed consent document.

NOTE: Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available are not eligible.

- Patient must not have an ECOG Performance Status ≥ 3. OR Patient must not be deemed medically unable to participate in the study by the study investigators or an oncology clinician (i.e., referral to hospice).

- Patient must not be enrolled in other trials offering financial assistance.

NOTE: Gift cards for survey completion, parking passes, or free medication provided as part of therapeutic trials are not considered financial assistance.

Patient Eligibility Criteria for Step 1 (OPEN Randomization)

- Patient must meet all the eligibility criteria for Step 0 outlined in Section 3.2.1.

-Patient must have signed a written informed consent form.

- Patient must have completed Baseline Survey within 30 days of the date of Step 0 Registration.

- Patients must have initiated their CDK 4/6 inhibitors within 30 days of the date of Step 0 Registration. 

**PLEASE SEE THE CURRENT VERSION OF PROTOCOL FOR FULL ELIGIBILITY LIST** 

Step 0 Eligibility: **Check for eligibility to EAQ152 COMET Step 1**
Please note: it is estimated to take 6-8 weeks to be assigned to a treatment on this trial.
-Patients must have histologically documented solid tumors or histologically confirmed diagnosis of lymphoma or multiple myeloma that has progressed following at least one line of standard systemic therapy and/or for whose disease no standard treatment exists that has been shown to prolong survival.
-Patients must have measurable disease.
-Patients must meet one of the following:
--have tumor amenable to image guided or direct vision biopsy and be willing and able to undergo a tumor biopsy for molecular profiling. Biopsy must not be considered to be more than minimal risk to the patient. OR
--will be undergoing a procedure due to medical necessity during which the tissue may be collected OR
--tissue blocks collected within 6 mo prior to pre-reg are available for a patient who has not received any intervening therapy that is considered to be targeted- the patient may have received cytoxic chemo for up to 4 cycles but must not have responded
-Patient must not require the use of full dose coumadin-derivative anticoagulants such as warfarin. Low molecular weight heparin is permitted for prophylactic or therapeutic use. Factor X inhibitors are permitted.
-Patients must have ECOG performance status 0- 1
-Any prior therapy, radiotherapy (except palliative radiation therapy of 30 Gy or less), or major surgery must have been completed greater than or equal to 4 weeks prior to treatment on MATCH and patient must be recovered from adverse events due to prior therapy (except alopecia and lymphopenia)
-Palliative radiation therapy must have been completed at least 2 weeks prior to enrollment on a MATCH treatment arm and patient must have recovered from any adverse events of this therapy.
-Patients with brain metastases or primary brain tumors must have completed treatment, surgery or radiation therapy greater than or equal to 4 weeks prior to registration.
-NOTE: patients may receive non-protocol treatment after biopsy until they receive notification of results as specified per protocol; however, patients will need to be off of therapy for at least 4 weeks before receiving MATCH treatment.
-Patients with brain mets or primary brain tumors must have completed tx, surgery or RT at least 4 weeks prior to tx.
-Patients must have discontinued steroids greater than or equal to 1 week prior to registration (see protocol for exceptions). Patients with glioblastoma (GBM) must have been on stable dose of steroids, or be off steroids, for one week prior to registration
-No factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval

Step 1 Eligibility:

-See the specific subprotocol eligibility
-Some patients may be eligible to have their results rerun in Matchbox, even if they did not match to a treatment initially. See protocol for details.

Step 2 Eligibility:
-Patient's disease has progressed on Step 1 treatment or could not tolerate assigned treatment.
-Patients must meet one of the following criteria:
--No response and progression occurred less than 6 months from start of Step 1 treatment AND the MATCH assay results (received during Step 0) indicated > 1 targeted treatment.
--Progression occurred after a (1) response OR (2) after greater than or equal to 6 months from start of Step 1 treatment. 
-Patients must meet eligibility criteria for biopsy

Patient can be registered to subsequent steps depending on eligibility for further subprotocols.

Subprotocol E Eligibility (in addition to master):
-Patients must have either:
--Any malignancy other than non-small cell lung cancer and have EGFR T790M identified in their tumor, with or without an activating mutation OR
--Any malignancy harboring any of the following mutations: EGFR G719A, G719C, G719D, G719S EGFR L861Q, S786I or an EGFR exon 19 in frame insertion mutation
-Patients must have an ECG within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG .
-Patients must have an ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a LVEF < institutional LLN.
-Patients must not have known hypersensitivity to AZD9291 or compounds of similar chemical or biologic composition.
-Patient must not have received AZD9291, WZ4002, CO-1686, HM61713, EGF816 or ASP8273 previously.
-Patients known to harbor germline EGFR T790M mutations are excluded from the study. Prospective testing for germline mutations is not required.

Subprotocol F Eligibility (in addition to master):
-Patients must have an ALK rearrangement as determined by the MATCH screening assessment.
-Patients must not have non small cell lung cancer or ALCL.
-Patients with a history of interstitial lung disease or pneumonitis are excluded.
-Patients must have an ECG within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG
-Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition.
-Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment.

Subprotocol G Eligibility (in addition to master):
-Patients must be positive for translocation or inversion events involving the ROS1 gene as detected on the MATCH NGS assay
-Patients must not have adenocarcinoma of the lung.
-Patients with a history of interstitial lung disease or pneumonitis are excluded.
-Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG
-Patients must not have known hypersensitivity to crizotinib or compounds of similar chemical or biologic composition.
-Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib, ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072, KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922